Clinical Trial

A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.

Study acronym: SOSA
Recruiting
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Summary
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep Clinic. The main question it aims to answer are: \- Does Sunrise lead to a higher proportion of definitive management decisions (initiate OSA treatment, discharge from the sleep clinic service, additional diagnostic testing required or a clinic appointment) compared to current screening practices, which includes either overnight oximetry or use of a wearable device called WatchPAT 300? Researchers will compare Sunrise results with oximetry and WatchPAT 300 outcomes to see if Sunrise improves diagnostic efficiency, reduces time to a diagnosis or clinical decision and enhances patient experience. Participants will: * Follow the standard clinical pathway (oximetry or WatchPAT 300) * Use the Sunrise device simultaneously for one night with their usual test * Complete a patient feedback questionnaire on ease of use and experience * Return all equipment two days later, Sunrise results will not affect their clinical care and will be used for the study only
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-25.
Trial Details
NCT Number NCT07269483
Lead Sponsor Virginia Hawkins
Collaborators: University Hospitals Bristol and Weston NHS Foundation Trust
Conditions Obstructive Sleep Apnoea (OSA)
Enrollment 100 participants
Start Date 2025-07-28
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-19